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FreeStyle Libre 2

FreeStyle Libre 2

Manufacturer:

Abbott Diabetes Care

Distributor:

Abbott
Concise Prescribing Info
Contents
Flash glucose monitoring system
Indications/Uses
Measuring interstitial fluid glucose levels in people (≥2 yr) w/ or w/o DM, including pregnant women. Designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin.
Dosage/Direction for Use
Refer to the included User's Manual in the Reader kit & product insert in Sensor kit for instructions.
Contraindications
Special Precautions
Do not ignore symptoms that may be due to low or high blood glucose. Check reading by conducting fingerstick test using blood glucose meter if patient has symptoms that do not match the Sensor glucose reading or suspect that the reading may be inaccurate. Contains small parts that may be dangerous if swallowed. Use w/ other implanted medical devices eg, pacemakers & use in persons on dialysis, or childn <2 yr have not been evaluated. Perform blood glucose test on the finger to confirm the glucose & check to make sure the Sensor has not come loose if glucose readings are not correct or are inconsistent w/ how patient feels. Single person use. Not to be used on >1 person including other family members due to risk of spreading infection. Remove the Sensor & stop using the System if significant skin irritation is noticed around or under the Sensor. Remove the Sensor the patient is wearing & apply a new one after if patient has medical appointment that includes strong magnetic or electromagnetic radiation eg, X-ray, MRI, or CT scan. Intense exercise may cause the Sensor to loosen due to sweat or movement of the Sensor. Avoid intense exercise; getting dust, dirt, blood, control soln, water or other substances in the Reader's USB & test strip ports. Do not reuse Sensors; designed for single use. Reuse may result in no glucose readings & infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results. Check that the Sensor codes match before using the Sensor Pack & Sensor Applicator. Designed to be used only w/ FreeStyle Optium blood glucose & blood ketone test strips & MediSense control soln. Childn (2-12 yr) is limited to those who are supervised by a caregiver who is at least 18 yr.
MIMS Class
Personal Care
ATC Classification
V07 - ALL OTHER NON-THERAPEUTIC PRODUCTS ; Other products with non-therapeutic properties.
Presentation/Packing
Form
FreeStyle Libre 2 Plus Sensor
Packing/Price
1's
Form
FreeStyle Libre 2 Reader
Packing/Price
1's
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